A Clinical Study for Developing Artificial Intelligence(AI)-Based Clustering Model for Personalized Medicine in Acute Respiratory Failure

NCT06479421 | Recruiting

• 1 other identifier: 2023-08-003
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory failure. and clinical characteristics and prognosis will be compared.

Conditions

Acute Respiratory Failure

Keywords

phenotyping; clustering analysis

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality

  clinical outcomes - Hospital Mortality

  From date of admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year

Secondary Outcomes (3)

• ICU Mortality

  From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 6 months

• Hospital length of stay

  From date of hospital admission until the date of hospital discharge, assessed up to 1 years

• ICU length of stay

  From date of ICU admission until the date of ICU discharge, assessed up to 6 months

Study Arms (2)

Acute Respiratory Failure group

Among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital, if all of the following conditions are met: 1. Age 18 or older 2. Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure.

Control group

For comparative analysis, among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital who meet all of the following conditions, they are registered as a control group with the consent of the subjects and undergo the same research procedure. 1. Age 18 or older 2. Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with acute respiratory failure admitted to the internal medicine intensive care unit of Samsung Seoul Hospital 1) Age 18 or older 2) Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure. 2. The following patients (control group) admitted to the internal medicine intensive care unit of Samsung Seoul Hospital 1) Age 18 or older 2) Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment

You may qualify if:

• \- Acute Respiratory Failure group
• Among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital, if all of the following conditions are met:
• \) Age 18 or older 2) Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure.
• \- control group For comparative analysis, among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital who meet all of the following conditions, they are registered as a control group with the consent of the subjects and undergo the same research procedure.
• Age 18 or older
• Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment

You may not qualify if:

• If any of the following criteria applies, participants will not be permitted to participate in this clinical trial.
• Patients 48 hours after oxygen treatment (HFNC, NIV (BIPAP or CPAP), MV)
• Patients transferred from another hospital
• Patients with limitations in treatment

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ministry of Science and ICT, Republic of Korea: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam, 06351, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Blood sample collection : Within 24 hours after admission to the intensive care unit, and 2 to 5 days after admission to the intensive care unit, 18 ml of blood is collected in an ethylenediaminetetraacetic acid(EDTA) tube once (a total of 2 times, 36 ml) to analyze the following. * Interleukin(IL)-6, IL-8, tumor necrosis factor receptor-1 levels, etc. will be checked. * If the planned sample collection time has passed after admission to the intensive care unit or if blood sample collection is difficult due to quarantine, etc., this can be omitted. 2. Broncho-Alveolar Lavage(BAL) fluid sample collection * Only for those subjects who undergo BAL during the treatment process, 5ml of BAL fluid will be collected and analyzed for the following. * IL-1β, IL-6, IL-8, Kerbs von Lungren-6, Plasminogen activator inhibitor-1, etc. will be checked.

Central Study Contacts

Ryoung Eun Ko, MD, PhD

CONTACT

+82-2-3410-6399; koryoungeun@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: August 14, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

KR (1)